Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering support within new product development, operational, or system/services support.
- Ensures that software validation is carried out in compliance with site/corporate policies and SOPs
- Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements
- Reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and where applicable Risk Assessments along with associated documentation for equipment and systems
- Verifies that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols
- Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team
- Provides guidance to staff across various functions on software validation to ensure best practice is maintained. Provides guidance and assistance when required with the preparation of validation protocols, software design specifications and associated documentation for equipment and systems
- Provides software validation/compliance/part 11 guidance in accordance with company policies and SOPs
- Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- HETAC level 8 degree (240 credits) in Science/Engineering/Software discipline
- Strong Leadership & influencing skills
- 5-8 years relevant experience within a software regulated environment.
To apply for this position please contact Catriona Coogan at Sigmar Recruitment T: +353 91 455306 E: email@example.com
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